Background and Importance Epclusa is a two-drug combination administered as a single daily pill containing Velpatasvir and Sofosbuvir used to treat de Hepatitis C. The treatment duration is 12 weeks and the cure rates are from 97% to 100% in those patients without cirrhosis or with compensated cirrhosis.

Based on data obtained from phase 3 clinical studies, the percentage of patients experiencing any serious adverse event was 3.2%. The most common adverse reactions observed are headache and fatigue.

Pharmacovigilance collects information, and analyses and notifies case of suspected adverse drug reactions (ADRs) to prevent them occurring in the future

Aim and Objectives To describe a case of sleepiness in a patient treated with Epclusa and establish its possible association.

Material and Methods We describe a case of an 72-year-old woman diagnosed with hepatitis C with compensated cirrhosis and treated with Epclusa. In May 2022, before starting the treatment with Epclusa, her home medication was checked at the Pharmacy Department, which include atorvastatin, enalapril and omperazole; pointing out to separate the intake of omeprazole and Epclusa 4 hours and proving there no were any drug interactions. After 16 days receiving the treatment with Eplcusa, she was referred to the emergency department presenting sleepiness and general deterioration. As a result, she was diagnosed with common cold and treated with amoxicilin. It also coincided with constipation, which spontaneously resolved within two days. Finally Epclusa treatment was stopped.

Results 4 days after, she reported improvement in sleepiness after discontinuation of treatment, although the iatrogenic origin cannot be guaranteed since it has also coincided with catarrhal symptoms and constipation, both situations in resolution. Naranjo’s algorithms establish the causality relationship as possible (score of 2). The Spanish pharmacovigilance centre was notified.

Conclusion and Relevance The European Medicines Agency’s technical sheet for Epclusa does not describe sleepiness as an ADR. Patient could confuse fatigue with sleepiness in dealing with subjective symptoms. The RPC reported this case as the only Epclusa ADR notified in our country. The reporting of ADRs in hospitals is very important because innovative new drugs are usually used, severe ADRs are most likely to be seen in hospitals and it can be detected early helping others how to act.

Conflict of Interest No conflict of interest